Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Innova Vascular, Inc.
Study ID
NCT06041594
Status
Recruiting
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Conditions

  • Pulmonary Embolism

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Laguna Thrombectomy System — DEVICE
    Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism

Study Details

This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary embolism. The Laguna Thrombectomy System is an investigational device which consists of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured by Innova Vascular, Inc.

Key Dates

First listed
Sep 18, 2023
Start date
Aug 19, 2024
Status verified
Jul 2026
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
107 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Laguna Thrombectomy System

Primary Outcome Measure

A composite of the following major adverse events occurring within 48 (± 8) hours post-procedure: [ Time Frame: within 48 (± 8) hours post-procedure ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Grandview Medical CenterBirminghamAlabama35243-
University of ArizonaTucsonArizona85724-
University of California IrvineIrvineCalifornia92697-
Memorial Care Long Beach Medical CenterLong BeachCalifornia90806-
Mission Hospital Regional Medical CenterMission ViejoCalifornia92691-
St. Joseph Hospital of OrangeOrangeCalifornia92868-
George Washington UniversityWashington D.C.District of Columbia20037-
Manatee Memorial HospitalBradentonFlorida34209-
Physicians Regional Medical CenterNaplesFlorida34119-
AdventHealth TampaTampaFlorida33613-
Rush University Medical CenterChicagoIllinois60612-
Albany Medical CenterAlbanyNew York12210-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
OhioHealth Research InstituteColumbusOhio43214-
Turkey Creek Medical CenterKnoxvilleTennessee37934-
University of Texas SouthwesternDallasTexas75390-

Find similar trials in Birmingham, AL

By research site
Grandview Medical Center· Birmingham, ALUniversity of Arizona· Tucson, AZUniversity of California Irvine· Irvine, CAMemorial Care Long Beach Medical Center· Long Beach, CAMission Hospital Regional Medical Center· Mission Viejo, CASt. Joseph Hospital of Orange· Orange, CA

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